Lifecycle-based commissioning, qualification, and validation support for facilities, utilities, equipment, systems, and processes across regulated operations.

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Commissioning & Qualification Structured commissioning and qualification support to verify that facilities, utilities, equipment, and... Facility Qualification Structured qualification support to verify that pharmaceutical and life-sciences facilities are designed,... Utility Qualification Risk-based qualification support to demonstrate that critical utility systems are properly installed,... Equipment Qualification Structured qualification support to verify that equipment is properly installed, operates as... HVAC and Cleanroom Qualification Structured qualification support to verify that HVAC systems and cleanrooms consistently maintain... Process Validation Lifecycle-based process validation support to demonstrate that manufacturing processes consistently deliver products... Cleaning Validation Risk-based cleaning validation support to demonstrate effective removal of product residues, cleaning... Validation Master Plan Structured validation planning to define scope, responsibilities, priorities, documentation, and lifecycle control... Qualification Protocols & Reports Clear, traceable, and risk-based qualification documentation to support compliant execution, evidence review,... Periodic Review & Requalification Risk-based periodic review and requalification support to confirm that facilities, utilities, equipment,... Validation Lifecycle Support End-to-end validation lifecycle support to help maintain facilities, utilities, equipment, systems, and...

02 · CSV & DIGITALIZATION

Risk-based computerized-system validation, data-integrity, and digital compliance support across the GxP system lifecycle.

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Computer System Validation Lifecycle-based validation support to demonstrate that GxP computerized systems are fit for... Data Integrity Assessment Structured assessment of data governance, systems, processes, and controls to help ensure... 21 CFR Part 11 Compliance Compliance support for electronic records and electronic signatures used in FDA-regulated GxP... Digital QMS Compliance-focused support for implementing, validating, optimizing, and maintaining electronic Quality Management Systems... Computer Software Assurance Risk-based software assurance focused on critical functions, intended use, patient safety, product... GAMP 5 Compliance Risk-based GxP computerized-system lifecycle support aligned with GAMP 5 principles for reliable,... EU Annex 11 Compliance Lifecycle-based compliance support for computerized systems used in GMP-regulated environments, with focus... Electronic Document Management Systems Compliance-focused support for implementing, validating, and maintaining controlled electronic document-management systems across... Data Migration Validation Risk-based validation support to help ensure that GxP data transferred between systems... Interface & API Validation Risk-based validation support for system-to-system interfaces and APIs to help ensure complete,... Cloud System Assessment Risk-based assessment and compliance support for cloud-hosted GxP applications, infrastructure, data, suppliers,... Vendor & System Qualification Risk-based qualification of software vendors, service providers, and GxP computerized systems to... Digital Transformation Support Compliance-focused digital transformation support to help regulated organizations modernize processes, systems, workflows,...

03 · EHS, ENERGY & SUSTAINABILITY

Integrated environment, health, safety, energy, and sustainability solutions to support safer operations, regulatory compliance, resource efficiency, and long-term performance.

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Energy Practical energy-management solutions to help organizations reduce energy consumption, improve utility efficiency,... EHS Practical EHS solutions to help organizations manage workplace risks, strengthen compliance, improve... Sustainability Practical sustainability solutions to help organizations improve resource efficiency, reduce waste, strengthen...

04 · GXP AUDITS & ASSESSMENTS

Independent, risk-based audits and compliance assessments to strengthen quality systems, identify regulatory gaps, and support inspection readiness.

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05 · PHARMACEUTICAL ENGINEERING & FACILITY SOLUTIONS

GMP-focused engineering and facility solutions from concept development through design, implementation, qualification, and operational readiness.

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Equipment Selection & Technical Evaluation Structured equipment selection and technical evaluation support to improve process fit, GMP... HVAC & Cleanroom Qualification Specialized HVAC and cleanroom engineering support to maintain environmental control, contamination control,... Conceptual, Basic and Detailed Engineering Integrated engineering support from early concept through detailed design to help deliver... New Facility Planning & Design Integrated facility planning and design support to build compliant, efficient, scalable, and... GMP Engineering Compliance Engineering compliance support to align facilities, utilities, equipment, and technical systems with... Utility Systems Design & Assessment Engineering support for reliable, compliant, and efficient utility systems serving pharmaceutical and... Engineering Project Management Structured project-management support to coordinate engineering, quality, vendors, timelines, risks, and execution... Procurement Support Technical procurement support to improve vendor selection, specification control, commercial clarity, and... Construction & Installation Support On-site and technical execution support to help ensure that pharmaceutical facilities, utilities,... High-Potency & Containment Facility Design Specialized facility and engineering support for high-potency, hazardous, and containment-sensitive manufacturing environments. Turnkey Engineering Support Integrated engineering support from concept and design through execution, coordination, qualification interface,... Green Building & Sustainable Facility Design Sustainable facility planning and engineering support to improve energy efficiency, resource utilization,... Facility Layout Review Independent GMP-focused layout review to improve flow, segregation, contamination control, operational efficiency,...

06 · PHARMACOVIGILANCE SERVICES

End-to-end pharmacovigilance and drug-safety support across the product lifecycle to help organizations manage safety information, regulatory obligations, and patient-risk monitoring.

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ICSR Case Management End-to-end Individual Case Safety Report processing support to help ensure complete, accurate,... Safety Database Management Reliable safety database support to help ensure accurate case capture, controlled workflows,... Signal Management Structured signal detection, assessment, prioritization, and tracking support to help identify and... Literature Monitoring Structured literature surveillance to identify reportable safety information, emerging risks, and relevant... Aggregate Reporting Structured aggregate safety reporting support to help organizations evaluate cumulative safety data,... Risk Management Structured pharmacovigilance risk-management support to identify, characterize, monitor, minimize, and communicate important... PV SOP Development Practical, role-based pharmacovigilance SOP development to help organizations standardize safety activities, define... PV Training Practical, role-based pharmacovigilance training designed to strengthen safety knowledge, operational consistency, regulatory... SDEA/PVA Management Structured safety agreement support to clearly define pharmacovigilance responsibilities, safety-data exchange requirements,... PSMF Support Structured Pharmacovigilance System Master File support to help organizations document, maintain, and... PV Quality & Compliance Quality-system and compliance support to help organizations maintain controlled, consistent, traceable, and...

07 · PRODUCT DEVELOPMENT & TECHNOLOGY TRANSFER

Technical support for product and process development, scale-up, optimization, and structured technology transfer across pharmaceutical operations.

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Product Development Support Structured technical support to help pharmaceutical and life-sciences organizations plan, develop, evaluate,... Process Development Technical process-development support to help establish robust, reproducible, scalable, and manufacturable processes... Analytical Development Support Technical support for analytical method planning, development coordination, method transfer, validation readiness,... Technology Transfer Structured technology-transfer support to help ensure that product, process, analytical, and manufacturing... Scale-Up Support Structured technical support to help transition pharmaceutical products and processes from development... Process Optimization Technical process-optimization support to improve robustness, reproducibility, efficiency, yield, and overall manufacturing... Technical Troubleshooting Structured technical troubleshooting support to identify root causes, resolve recurring manufacturing or... Formulation Development Support Technical support for formulation planning, evaluation, optimization, and documentation to help develop...

08 · QUALITY & COMPLIANCE

Practical quality-system and compliance support to strengthen control, improve consistency, and maintain inspection readiness.

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Change Control Structured change-control support to assess impact, manage risk, and maintain the validated... Quality Management System Development Structured QMS development and improvement support to strengthen governance, compliance, consistency, and... CAPA Management Structured CAPA support to address root causes, prevent recurrence, and strengthen quality-system... Deviation & OOS/OOT Management Structured investigation and quality-event management support to identify root causes, reduce recurrence,... Data Integrity & Good Documentation Practices Practical data-integrity and documentation support to strengthen record reliability, traceability, accountability, and... Quality Risk Management (QRM) Structured, science-based risk management support to identify, evaluate, control, communicate, and review... Gap Assessment & Remediation Structured compliance gap assessments and practical remediation support to strengthen systems, reduce... SOP Development & Review Practical SOP development and lifecycle support to standardize processes, strengthen compliance, and... Contamination Control Strategy Structured contamination-control support to identify contamination risks, strengthen preventive controls, and maintain... Inspection Readiness Structured inspection-readiness support to strengthen systems, prepare teams, and reduce regulatory risk... Quality Metrics & Management Review Structured quality-performance monitoring and management-review support to strengthen oversight, identify trends, and...

09 · REGULATORY STRATEGY & INTELLIGENCE

Strategic and operational regulatory support across product development, submissions, approvals, and lifecycle management.

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Medical & Regulatory Writing Clear, accurate, and compliant scientific writing support for regulatory, clinical, safety, and... Regulatory Strategy and Intelligence Practical regulatory planning and intelligence support to help organizations understand requirements, select... Dossier Compilation & Review Structured dossier preparation and technical review support to improve completeness, consistency, and... CTD/eCTD Support Structured CTD and eCTD support to improve dossier organization, technical consistency, and... Regulatory Submission Support Coordinated regulatory submission support to improve completeness, consistency, and readiness across application... Regulatory Query Response Support Structured support for assessing, coordinating, drafting, and tracking responses to regulatory authority... Product Registration Support Structured product registration support to help organizations prepare compliant documentation, coordinate submissions,... Variations & Renewals Structured post-approval regulatory support to manage product changes, maintain registrations, and ensure... Regulatory Lifecycle Management Ongoing regulatory support to maintain product approvals, manage post-approval obligations, and keep... Artwork & Labelling Review Regulatory and quality-focused review of product labelling and artwork to improve accuracy,... Regulatory Gap Assessment Structured regulatory assessments to identify documentation, compliance, and lifecycle gaps before they...

10 · TRAINING & CAPABILITY DEVELOPMENT

Practical, role-based training programs designed to strengthen GxP knowledge, compliance culture, technical capability, and workforce performance.

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Equipment Selection & Technical Evaluation HVAC & Cleanroom Qualification Conceptual, Basic and Detailed Engineering New Facility Planning & Design GMP Engineering Compliance Utility Systems Design & Assessment Engineering Project Management Procurement Support Construction & Installation Support High-Potency & Containment Facility Design Turnkey Engineering Support Green Building & Sustainable Facility Design Facility Layout Review

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Mediature GxP Solutions Private Limited provides professional GxP, GMP, quality, regulatory, pharmacovigilance and pharmaceutical consulting solutions to support quality, compliance and operational excellence.

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